Status:
WITHDRAWN
Study to Evaluate the Safety of ATR-04
Lead Sponsor:
Azitra Inc.
Conditions:
Epidermal Growth Factor
Papulopustular Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase 1b/2a study designed to evaluate the safety of an investigational product called ATR-04, to reduce the severity of epidermal g...
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled phase 1b/2a study designed to evaluate the safety of an investigational product called ATR-04 to reduce the severity of epidermal gr...
Eligibility Criteria
Inclusion
- Subject must be at least 18 years of age inclusive, at the time of signing the informed consent
- Subjects with a current diagnosis of cancer
- IGA grade of 0 on the face
- Life expectancy, in the Investigator's opinion, greater than 12 weeks
- Plan to initiate treatment with one of the following EGFRI drugs (other treatments may be considered after consultation with the Sponsor): Cetuximab or Panitumumab or erlotinib
- Able to use Dove sensitive skin body wash for the duration of the treatment period.
- Acceptable and willing to delay start of EGFRI therapy until study eligibility is determined
- Anticipated to continue EGFRI therapy for at least 28 days after the first application of study medication
- Male and/or female
- Contraceptive use by men or women consistent with the EGFRI treatment package insert regarding the methods of contraception for those participating in clinical studies
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.
Exclusion
- Active bacterial skin infections on the face
- Inter-current illness that in the Investigator's opinion puts the subject at undue risk by study participation or interfere with the study conduct or evaluations
- Pregnant women
- EGFRI therapy within the previous 12 weeks
- Radiation therapy exposure to the face within the previous 8 weeks
- Use of topical steroids on the face within the previous 4 weeks
- Use of systemic antibiotics or topical antibiotics on the face in the previous 7 days
- Participation in an investigational clinical study in which administration of an investigational study medication occurred with the previous 30 days
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04731259
Start Date
January 1 2024
End Date
January 1 2026
Last Update
October 3 2025
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